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New Scientist Live

Personalised cancer trial promises better drugs faster

By Peter Aldhous

Major changes to the way cancer drugs are tested in people could lead to better and cheaper therapies coming to the market more quickly.

A breast cancer trial called I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis 2) was launched today by a US consortium including the National Institutes of Health, the Food and Drug Administration and leading pharmaceutical companies. It is expected to involve up to 800 patients, recruited at up to 20 leading cancer centres across the US.

It is radically different to conventional clinical trials because it will test several drugs at once and allows doctors to adapt the recruitment of patients based on incoming results and to drop ineffective drugs quickly.

Drugs that show promising results will be given to more patients with types of tumours that seem likely to respond.

But there’s a big problem&colon; it currently takes longer than 12 years and according to some estimates more than &dollar;1 billion to get a new cancer drug into clinical use.

This is where I-SPY 2 TRIAL comes in. Rather than testing one drug at a time, the trial will cut through the red tape that binds individual drug trials by testing up to 12 experimental therapies from a variety of companies.

Women with breast cancer will be given the most suitable current treatment plus one of the new drugs, to see which are best at shrinking tumours before surgery. This will be measured by magnetic resonance imaging, providing the fastest possible results.

The women’s tumours will be checked for biomarkers that are known to affect how well existing therapies work – such as receptors for the sex hormone oestrogen. –

Patients will also be assessed for experimental biomarkers, including patterns of gene activity and protein production, and variations in the number of copies of particular genes.

This will allow the researchers to discover which drugs are working best in which patients, according to their tumours’ molecular profiles.

Learn faster

“I-SPY 2 will provide a path to personalised medicine,” says Laura Esserman of the University of California, San Francisco, who is leading the trial with Donald Berry of the University of Texas M. D. Anderson Cancer Center in Houston.

Crucially, Berry – a specialist in biostatistics – has designed the trial so that results can be assessed quickly and successful drugs can then be given to more patients as soon as they are shown to be beneficial. “We have set up a system where everyone can learn faster,” says Esserman.

This should improve the efficiency of subsequent phase-III trials – the huge and costly studies needed before a drug can be approved for use – by ensuring that drugs are given only to women with tumours that are likely to respond. The researchers hope to reduce overall development times by several years and slash costs by hundreds of millions of dollars per drug.

Price control

“This is the type of study that is absolutely needed if we’re going to make progress in developing personalised therapies,” says Ramesh Ramanathan, medical director of the TGen Clinical Research Services Clinic in Scottsdale, Arizona, who is not involved in the trial.

But some activists warn that reducing development costs won’t necessarily make cancer therapies affordable – especially in the US, where the federal government has not stepped in to curb the extremely high prices charged for the current generation of targeted drugs. “If we don’t control drug prices, we’ll never get there,” argues Barbara Brenner, executive director of Breast Cancer Action, based in San Francisco.